Application Sponsors
| ANDA 079213 | ZYDUS PHARMS USA INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 75MG | 0 | IRBESARTAN | IRBESARTAN |
| 002 | TABLET;ORAL | 150MG | 0 | IRBESARTAN | IRBESARTAN |
| 003 | TABLET;ORAL | 300MG | 0 | IRBESARTAN | IRBESARTAN |
FDA Submissions
| ORIG | 1 | AP | 2012-09-27 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-11-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ZYDUS PHARMS USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 79213
[companyName] => ZYDUS PHARMS USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IRBESARTAN","submission":"IRBESARTAN","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IRBESARTAN","submission":"IRBESARTAN","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IRBESARTAN","submission":"IRBESARTAN","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)